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FDA Medical Device Recalls (openFDA)

Medline Industries, LP: Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5667; 7) WASTE MANAGEMENT KIT - 2, Model Number: DYNJWASTEKIT2; 8) CARDIAC CATH, Model Number: DYNJ20175J; 9) D&C PACK-POB, Model Number: DYNJ33521D; 10) BASIC PACK, Model Number: DYNJ38533F; 11) CATH PACK IMPLANT, Model Number: DYNJ39230D; 12) CERVICAL SPINE PACK, Model Number: DYNJ40886B; 13) MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553F; 14) TV ENDOVASCULAR-LF, Model Number: DYNJ41558D; 15) MAJOR PACK-LF, Model Number: DYNJ44816J; 16) ANGIOGRAPHY PACK, Model Number: DYNJ48683A; 17) EXTREMITY PACK, Model Number: DYNJ55922C; 18) NEURO PACK, Model Number: DYNJ57785C; 19) PACEMAKER PACK, Model Number: DYNJ61377B; 20) VASCULAR PACK, Model Number: DYNJ62683D; 21) LINQ INSERTION PK W/OUT LIDO, Model Number: DYNJ63668B; 22) BASIC PACK, Model Number: DYNJ83324; 23) OMF MINOR PACK, Model Number: DYNJ83991B; 24) ARTERIOGRAM SUMMIT PACK, Model Number: DYNJ84040B; 25) HMWB NEURO NAMIC PACK, Model Number: DYNJ86600; 26) VCH CARDIAC CATH PACK, Model Number: DYNJ89064; 27) RADIOLOGY PACK, Model Number: DYNJ89080; 28) LITHOTOMY PACK, Model Number: DYNJ89959; 29) AHT SPINE PACK, Model Number: DYNJ903566D; 30) LAP, Model Number: DYNJ904576B; 31) EP MERCY JANESVILLE, Model Number: DYNJ907013; 32) LHK, US, RUBY MEMORIAL HOSP, Model Number: NAM0032; 33) CHERIAN CATH KIT, Model Number: VASC1086; 34) RIGHT HEART KIT - LAKE NONA, Model Number: VASC1120; 35) KIT ANGIO CSTM-SHAWNEE, Model Number: VASC1151; 36) LEFT HEART KIT - OAKBEND, Model Number: VASC1155; 37) IR 2 PORT-ARROWHEAD REGIONAL, Model Number: VASC1404; 38) LHK - ARROWHEAD REGIONAL MED, Model Number: VASC1405; 39) LHK - UMC DOUBLE TRANSDUCER, Model Number: VASC1415A; 40) SDMC, EP TWO PORT CUSTOM KIT, Model Number: VASC1533; 41) ARTERIOGRAM TRAY, Model Number: 00-402001V

Recall number
Z-1842-2026
Recalling firm
Medline Industries, LP
Product
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5667; 7) WASTE MANAGEMENT KIT - 2, Model Number: DYNJWASTEKIT2; 8) CARDIAC CATH, Model Number: DYNJ20175J; 9) D&C PACK-POB, Model Number: DYNJ33521D; 10) BASIC PACK, Model Number: DYNJ38533F; 11) CATH PACK IMPLANT, Model Number: DYNJ39230D; 12) CERVICAL SPINE PACK, Model Number: DYNJ40886B; 13) MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553F; 14) TV ENDOVASCULAR-LF, Model Number: DYNJ41558D; 15) MAJOR PACK-LF, Model Number: DYNJ44816J; 16) ANGIOGRAPHY PACK, Model Number: DYNJ48683A; 17) EXTREMITY PACK, Model Number: DYNJ55922C; 18) NEURO PACK, Model Number: DYNJ57785C; 19) PACEMAKER PACK, Model Number: DYNJ61377B; 20) VASCULAR PACK, Model Number: DYNJ62683D; 21) LINQ INSERTION PK W/OUT LIDO, Model Number: DYNJ63668B; 22) BASIC PACK, Model Number: DYNJ83324; 23) OMF MINOR PACK, Model Number: DYNJ83991B; 24) ARTERIOGRAM SUMMIT PACK, Model Number: DYNJ84040B; 25) HMWB NEURO NAMIC PACK, Model Number: DYNJ86600; 26) VCH CARDIAC CATH PACK, Model Number: DYNJ89064; 27) RADIOLOGY PACK, Model Number: DYNJ89080; 28) LITHOTOMY PACK, Model Number: DYNJ89959; 29) AHT SPINE PACK, Model Number: DYNJ903566D; 30) LAP, Model Number: DYNJ904576B; 31) EP MERCY JANESVILLE, Model Number: DYNJ907013; 32) LHK, US, RUBY MEMORIAL HOSP, Model Number: NAM0032; 33) CHERIAN CATH KIT, Model Number: VASC1086; 34) RIGHT HEART KIT - LAKE NONA, Model Number: VASC1120; 35) KIT ANGIO CSTM-SHAWNEE, Model Number: VASC1151; 36) LEFT HEART KIT - OAKBEND, Model Number: VASC1155; 37) IR 2 PORT-ARROWHEAD REGIONAL, Model Number: VASC1404; 38) LHK - ARROWHEAD REGIONAL MED, Model Number: VASC1405; 39) LHK - UMC DOUBLE TRANSDUCER, Model Number: VASC1415A; 40) SDMC, EP TWO PORT CUSTOM KIT, Model Number: VASC1533; 41) ARTERIOGRAM TRAY, Model Number: 00-402001V
Status
Open, Classified
Initiated
2026-02-25
Posted
2026-04-17
Terminated
not on file
Reason
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Root cause
No Marketing Application
Action
An URGENT MEDICAL DEVICE RECALL dated 2/25/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and lot number(s) listed in the recall portal. Quarantine all affected product. 2. Complete your response form. List the quantity of affected product you have in inventory on the form. Even if you do not have any affected product, submit the form to Website link: https://recalls.medline.com Recall Reference #: R-26-020-FGX1 Recall Code: 3. When we receive your response form, we will send over-labels via FedEx overnight to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Include your customers quantities on your response form. When we receive your response form, we will send over-labels to provide to your customers. Any questions? Contact the Recall Department at 866-359-1704 or recalls@medline.com. *** An Urgent Medical Device Recall notification letter dated 3/2/26 was sent to customers. This is a follow-up to a Medline notification you may have received on February 25, 2026. New item numbers and lot numbers have been included with this communication. Recipients receiving this notification for the first time were not affected by the original notification. REQUIRED ACTIONS: same as for 2/25/26 letter
Quantity
38014 units
Distribution
US Nationwide distribution.
Lot, serial or model codes
1) DYKB1038, UDI-DI: 10193489502428(each), 40193489502429(case), Lot Number: 22GBJ869; 2) DYNDA3188, UDI-DI: 10198459303579(each), 40198459303570(case), Lot Number: 25DBF256; 3) DYNJG001027B, UDI-DI: 10198459065453(each), 40198459065454(case), Lot Number: 25ELA998; 4) DYNJG001027B, UDI-DI: 10198459065453(each), 40198459065454(case), Lot Number: 25ELA723; 5) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21BBH579; 6) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21BBS213; 7) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21DBS220; 8) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21HBK178; 9) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21IBV194; 10) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBJ063; 11) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBM583; 12) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22ABG678; 13) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22ABZ724; 14) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22DBL342; 15) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22IBS978; 16) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22JBV884; 17) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22LBH141; 18) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE023; 19) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE024; 20) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE025; 21) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23CBP389; 22) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23EBB429; 23) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23EBQ437; 24) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23GBB278; 25) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23HBD985; 26) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23JBN242; 27) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23LBP034; 28) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23LBP432; 29) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24ABA416; 30) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24EBF244; 31) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24FBB647; 32) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24FBO960; 33) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24GBE249; 34) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24GBW947; 35) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24HBN439; 36) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24JBC123; 37) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24KBI920; 38) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24LBO860; 39) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBV362; 40) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23BBU890; 41) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24ABN982; 42) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 25HBM032; 43) DYNJT3719, UDI-DI: 10198459347054(each), 40198459347055(case), Lot Number: 25EBU996; 44) DYNJT5667, UDI-DI: 10198459492129(each), 40198459492120(case), Lot Number: 25HDB174; 45) DYNJWASTEKIT2, UDI-DI: 10193489548204(each), 40193489548205(case), Lot Number: 22HBK640; 46) DYNJ20175J, UDI-DI: 10198459023750(each), 40198459023751(case), Lot Number: 25DMI117; 47) DYNJ20175J, UDI-DI: 10198459023750(each), 40198459023751(case), Lot Number: 25BMC155; 48) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24FDB534; 49) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24HDC006; 50) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24IDB770; 51) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24KDA884; 52) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24LDA938; 53) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25ADB529; 54) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25BDB719; 55) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25DDB454; 56) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25HDA895; 57) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24DBD251; 58) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24EBF801; 59) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24FBD925; 60) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24GBY008; 61) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24HBN127; 62) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24JBT025; 63) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24KBF095; 64) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24LBK225; 65) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25BBA827; 66) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25CBF946; 67) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25DBH070; 68) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25EBK903; 69) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 24GBC776; 70) DYNJ38533F, UDI-DI: 10195327609931(each), 40195327609932(case), Lot Number: 25GBS410; 71) DYNJ39230D, UDI-DI: 10198459223679(each), 40198459223670(case), Lot Number: 25BBB333; 72) DYNJ39230D, UDI-DI: 10198459223679(each), 40198459223670(case), Lot Number: 25CBI608; 73) DYNJ40886B, UDI-DI: 10193489768282(each), 40193489768283(case), Lot Number: 25ELA632; 74) DYNJ41553F, UDI-DI: 10198459079634(each), 40198459079635(case), Lot Number: 25EMI492; 75) DYNJ41558D, UDI-DI: 10889942811663(each), 40889942811664(case), Lot Number: 25EMC747; 76) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 24HBE996; 77) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 24IBD804; 78) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 24JBH568; 79) DYNJ44816J, UDI-DI: 10198459087318(each), 40198459087319(case), Lot Number: 25EBR969; 80) DYNJ48683A, UDI-DI: 10889942491377(each), 40889942491378(case), Lot Number: 24LBO769; 81) DYNJ55922C, UDI-DI: 10198459368318(each), 40198459368319(case), Lot Number: 25FMA909; 82) DYNJ55922C, UDI-DI: 10198459368318(each), 40198459368319(case), Lot Number: 25EMJ828; 83) DYNJ57785C, UDI-DI: 10195327543624(each), 40195327543625(case), Lot Number: 24BBN969; 84) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24CBB176; 85) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24DBR422; 86) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24FBO638; 87) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24HBT927; 88) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24IBP969; 89) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24JBH473; 90) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 24KBG036; 91) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 25CBH396; 92) DYNJ61377B, UDI-DI: 10195327592554(each), 40195327592555(case), Lot Number: 25EBE869; 93) DYNJ62683D, UDI-DI: 10195327556518(each), 40195327556519(case), Lot Number: 24ABP681; 94) DYNJ63668B, UDI-DI: 10195327550851(each), 40195327550852(case), Lot Number: 24HME110; 95) DYNJ83324, UDI-DI: 10195327260781(each), 40195327260782(case), Lot Number: 23BMD400; 96) DYNJ83324, UDI-DI: 10195327260781(each), 40195327260782(case), Lot Number: 23AMA569; 97) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24HBS684; 98) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24JBP876; 99) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24JBS147; 100) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 24LBL583; 101) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 25CBP938; 102) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 25DBQ919; 103) DYNJ83991B, UDI-DI: 10198459087325(each), 40198459087326(case), Lot Number: 25FBD407; 104) DYNJ84040B, UDI-DI: 10198459254161(each), 40198459254162(case), Lot Number: 25BMG397; 105) DYNJ86600, UDI-DI: 10198459021565(each), 40198459021566(case), Lot Number: 25BBT025; 106) DYNJ89064, UDI-DI: 10198459230820(each), 40198459230821(case), Lot Number: 25ABL031; 107) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25ABS218; 108) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25BBC477; 109) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25CBC491; 110) DYNJ89080, UDI-DI: 10198459232749(each), 40198459232740(case), Lot Number: 25DBC830; 111) DYNJ89959, UDI-DI: 10198459300912(each), 40198459300913(case), Lot Number: 25DBD397; 112) DYNJ903566D, UDI-DI: 10195327560829(each), 40195327560820(case), Lot Number: 25HBU069; 113) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21FBN722; 114) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21HBI274; 115) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21IBL093; 116) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21KBE009; 117) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21LBG338; 118) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 22GBZ027; 119) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 22JMB507; 120) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 22KMC060; 121) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23BMF719; 122) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23CME266; 123) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23FMI182; 124) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23GMI509; 125) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23JME302; 126) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23KMI130; 127) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23LMH540; 128) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24BMA155; 129) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24GME966; 130) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24IMC690; 131) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 24KMG557; 132) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 21GBO411; 133) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 23FMC753; 134) DYNJ904576B, UDI-DI: 10888277776760(each), 40888277776761(case), Lot Number: 25GMD612; 135) DYNJ907013, UDI-DI: 10193489318630(each), 40193489318631(case), Lot Number: 25FLA929; 136) NAM0032, UDI-DI: 10195327694357(each), 40195327694358(case), Lot Number: 24LBG464; 137) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21DBF029; 138) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21GBV041; 139) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21IBQ150; 140) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21KBK856; 141) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 21LBA326; 142) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22CBX005; 143) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22EBO968; 144) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22HBF991; 145) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22IBR901; 146) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23ABL896; 147) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23ABN264; 148) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23DBA069; 149) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23DBM493; 150) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23EBH545; 151) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23FBF982; 152) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23HBE007; 153) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23IBE867; 154) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23JBW353; 155) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24ABL399; 156) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24CBB750; 157) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24CBP944; 158) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24EBQ247; 159) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24FBB644; 160) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24HBV207; 161) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 24KBI912; 162) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 25CBQ305; 163) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 25DBK904; 164) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 22JBD604; 165) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 23KBG280; 166) VASC1086, UDI-DI: 10889942668144(each), 40889942668145(case), Lot Number: 25EBH405; 167) VASC1120, UDI-DI: 10889942816316(each), 40889942816317(case), Lot Number: 25EBV199; 168) VASC1120, UDI-DI: 10889942816316(each), 40889942816317(case), Lot Number: 24FBD352; 169) VASC1151, UDI-DI: 10889942937523(each), 40889942937524(case), Lot Number: 25EBM012; 170) VASC1151, UDI-DI: 10889942937523(each), 40889942937524(case), Lot Number: 25EBD891; 171) VASC1155, UDI-DI: 10888277760493(each), 40888277760494(case), Lot Number: 25GBN921; 172) VASC1404, UDI-DI: 10195327366568(each), 40195327366569(case), Lot Number: 23EBI565; 173) VASC1405, UDI-DI: 10195327367015(each), 40195327367016(case), Lot Number: 25GBS655; 174) VASC1405, UDI-DI: 10195327367015(each), 40195327367016(case), Lot Number: 25DBJ392; 175) VASC1415A, UDI-DI: 10195327678272(each), 40195327678273(case), Lot Number: 24LBH191; 176) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24GBM956; 177) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24HBN734; 178) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24JBS224; 179) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24LBL061; 180) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25BBQ097; 181) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25CBK254; 182) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25CBN756; 183) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25CBU919; 184) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25DBG067; 185) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 24FBQ508; 186) VASC1533, UDI-DI: 10198459035623(each), 40198459035624(case), Lot Number: 25EBQ528; 187) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25ABG557; 188) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25BBE970; 189) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25CBN926; 190) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25EBD516; 191) 00-402001V, UDI-DI: 10198459235269(each), 40198459235260(case), Lot Number: 25EBP919
510(k) numbers
not on file
PMA numbers
not on file
Product code
LRO
Firm FEI
1417592
Firm city
Northfield
Firm state
IL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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